CMC Analytical Scientist - Gene Therapy (Onsite Durham)

Scorpion Therapeutics

Durham (NC)

On-site

USD 130,000 - 180,000

Full time

14 days+
Application generator

Get a reply from this employer — a resume and cover letter tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

Scorpion Therapeutics in Durham, NC is seeking a Hands-on Analytical Scientist in CMC for gene therapy programs. This onsite role focuses on developing and qualifying analytical methods, cell-based potency assays, and data review to support regulatory submissions.

The candidate will work with R&D, Quality, and Regulatory teams, applying GMP/ICH practices and contributing to stability and characterization activities for retinal disease programs.

Qualifications

  • B.S./M.S. in Biochemistry, Molecular Biology, Analytical Chemistry, or related field.
  • 4+ years in analytical development or QC in biotech/pharma.
  • Hands-on experience with AAV gene therapies and analytical techniques.

Responsibilities

  • Develop, qualify, transfer, troubleshoot analytical methods (identity, purity, potency, safety, stability).
  • Perform cell-based potency assays and bioanalytical tests (qPCR/ddPCR, ELISA, HPLC/UPLC).
  • Review external data and author technical documents.
  • Support regulatory submissions.
  • Collaborate across R&D, Quality, Regulatory.

Skills

Analytical development
Quality control
Technical writing
qPCR/ddPCR
AAV assays

Education

B.S./M.S. in Biochemistry
Molecular Biology
Analytical Chemistry

Tools

HPLC/UPLC
ELISA
qPCR/ddPCR
GMP
CDMO management

Job description

Scorpion Therapeutics in Durham, NC is seeking a Hands-on Analytical Scientist in CMC for gene therapy programs. This onsite role focuses on developing and qualifying analytical methods, cell-based potency assays, and data review to support regulatory submissions.

The candidate will work with R&D, Quality, and Regulatory teams, applying GMP/ICH practices and contributing to stability and characterization activities for retinal disease programs.

Get your free, confidential resume review.

or drag and drop your file here.

Similar jobs

Similar jobs worth comparing

Analytical Scientist, CMC
Analytical Scientist, CMC

Scorpion Therapeutics • Durham (NC)

On-site
USD 130,000 - 180,000
Director, Gene Therapy CMC Analytics
Director, Gene Therapy CMC Analytics

RhyGaze AG • Philadelphia

On-site
Confidential
Remote Director, Regulatory Affairs CMC - Gene Therapy
Remote Director, Regulatory Affairs CMC - Gene Therapy

Scorpion Therapeutics • United States

Hybrid
USD 250,000 - 350,000
(Associate) Director, CMC Analytical Development
(Associate) Director, CMC Analytical Development

RhyGaze AG • Philadelphia

On-site
Confidential
Director, Analytical Development & QC - Gene Therapy
Director, Analytical Development & QC - Gene Therapy

Cincinnati Children's • Cincinnati (OH)

On-site
USD 126,000 - 164,000
Senior QC & Analytical Development Scientist - Gene Therapy
Senior QC & Analytical Development Scientist - Gene Therapy

PACKGENE BIOTECH INC • Houston (TX)

On-site
USD 120,000 - 160,000
Associate Director, Analytical Sciences – Biologics
Associate Director, Analytical Sciences – Biologics

Implaion Recruiting • Durham (NC)

On-site
USD 180,000 - 240,000
CMC Regulatory Specialist: Biologics & Gene Therapy
CMC Regulatory Specialist: Biologics & Gene Therapy

CSL • Bridgeport

On-site
USD 95,000 - 125,000
CMC Regulatory Affairs Specialist - Biologics & Gene Therapy
CMC Regulatory Affairs Specialist - Biologics & Gene Therapy

CSL • Bridgeport

On-site
USD 95,000 - 125,000
Senior Analytical Sciences Lead – Cell & Gene Therapy
Senior Analytical Sciences Lead – Cell & Gene Therapy

Encoded Therapeutics Inc. • Raleigh (NC)

On-site
USD 110,000 - 170,000
Comprehensive benefits package
Stock option grants
Generous paid time off
+1